Improved method for detecting impurities in rotigotine

The invention relates to the field of medicine detection, and particularly provides an improved method for detecting impurities in rotigotine. Chromatographic conditions in the method comprise: a chromatographic column: # imgabs0 # C8, 150 mm * 4.6 mm, 3.5 [mu] m or # imgabs1 # C8 (2), 150 mm * 4.6...

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Bibliographische Detailangaben
Hauptverfasser: PENG LIJIAO, LI WENMING, LIU XIANGWEI, ZHANG JING
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention relates to the field of medicine detection, and particularly provides an improved method for detecting impurities in rotigotine. Chromatographic conditions in the method comprise: a chromatographic column: # imgabs0 # C8, 150 mm * 4.6 mm, 3.5 [mu] m or # imgabs1 # C8 (2), 150 mm * 4.6 mm, 3 [mu] m; a mobile phase A is 10mM K2HPO4 (the pH value is 7.2-7.5)-acetonitrile (90: 10); a mobile phase B is acetonitrile; the impurities comprise 4A; the method is high in specificity and sensitivity, the quality of the raw material medicine is more accurate and reliable, 4A and other known impurities can be detected at the same time, the technical problem that an existing detection method cannot detect the impurity 4A caused by a new process of the raw material medicine at the same time is solved, and technical guarantee is provided for medication safety. 本发明涉及医药检测领域,本发明具体提供了一种改进的罗替高汀中杂质的检测方法。本发明方法中的色谱条件包括:色谱柱:#imgabs0#C8,150mm*4.6mm,3.5μm或#imgabs1#C8(2),150mm*4.6mm,3μm;流动相A:10mM K2HPO4(pH值pH7.2-pH7.5)-乙腈(9